# FDA 483 - Advanced Instrumentations, Inc. - January 15, 2020

Source: https://www.globalkeysolutions.net/records/483/advanced-instrumentations-inc/fad51057-0429-44a5-842d-bbccefbc11a3

> FDA 483 for Advanced Instrumentations, Inc. on January 15, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Instrumentations, Inc.
- Inspection Date: 2020-01-15
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Advanced Instruments, Inc., a re-labeler and re-packager in Miami, FL, revealed significant deficiencies in their quality management system. Observations included inadequate corrective and preventive action procedures, incomplete complaint investigation records, and a lack of documentation for out-of-calibration equipment evaluations and remedial actions. These findings indicate a need for comprehensive improvements in their quality processes.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

Company: https://www.globalkeysolutions.net/companies/advanced-instrumentations-inc/4d9b9f1e-df18-4b76-ba69-fbb66b575fc4

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6